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Pfizer Research Chief’s Personal Take on Chantix
Posted by Scott Hensley
With questions about the safety of anti-smoking pill Chantix hurting sales, Pfizer’s head of R&D took to the opinion pages of the local paper in support of the medicine over the weekend.

Martin Mackay

Martin Mackay (pictured) wrote in the Day of New London, Conn., about his firsthand experience with the health toll of “cigarette addiction, having watched both of my parents smoke for most of their adult lives and my mother die of lung disease.”

His basic message was in keeping with points the company hit last week in a roundtable meeting with journalists. Quitting smoking is important, but hard. Chantix, despite some risks, remains a safe and effective option, in Pfizer’s view.

The drugmaker has upgraded the cautions on Chantix’s instructions to advise patients to stop taking Chantix in case of agitation, depression, or unusual behavior. Thoughts of suicide are a particular worry. A heightened concern about risk from Chantix led the FAA to ban the use of the drug by pilots and air-traffic controllers last month.

In his Chantix defense, Mackay couldn’t stop with data alone. He invoked some hometown pride in Chantix, one of Pfizer’s “homegrown” medicines.

The active ingredient in Chantix was invented by scientists in labs in Groton, Conn., on the eastern bank of the Thames River. On the opposite shore, in New London, other Pfizer workers designed and ran the clinical tests that led to the FDA’s approval of Chantix in May 2006. Pfizer employs 6,000 people in the area.

Does Smoking, Quitting Smoking, or Chantix throw you into Thyroid Problems?

Smoke free 205 Days!

As a lot of you know that follow my blog regularly, I had a comment by Joan that her and her twin sister had major side effects with Chantx involving their Thyroid. That prompted me to have mine checked. I went to the Doctor and had the blood work done and everything else checked while I was there. The nurse called yesterday with the results. I have HYPOTHYROIDISM and have to take a medication called Synthroid for the rest of my life! Don’t you think that is quite a coincidence? Well, I sure do. Actually, what are the odds that someone on the internet tells me about this new side effect of Chantix that I had not heard “scary stories” about and it turns out I have it too. Very strange in deed. So I decided to check this out for myself and here is what I have found out.

Does smoking cigarettes increase the odds of getting Hypothyroidism? That was my first question. Yes it does.

Smoking and Thyroid Diseases: The Connection

Smoking has been found to be one of the prominent causes of hypothyroidism and it has also been clear that smoke contains harmful ingredients that retard the functioning process of the thyroid gland. Many substances present in smoke trigger off anti-thyroid action inside the system and one among them is cyanide. On smoking cigarettes and other tobacco containing products, the ingredient cyanide enters the system and forms a specific compound thiocyanate.This new substance thiocyanate significantly prevents iodine intake and ensures the low production of thyroid hormones (hypothyroidism).

However, clinical studies have established that smokers are more prone to have thyroid enlargement which could be an indication of thyroid disturbance. Further, it has also been found that grave’s disease (thyroid eye disease) which is specifically responsible for hyperthyroidism can be triggered off on account of smoking. An article appeared in the Journal of the American Medical Association which makes it clear that people who are addicted to smoking are twice more likely to develop grave disease in comparison to non-smokers.

In a study involving women in Switzerland, Italy, the Netherlands and Sweden, it was found that smoking impairs both thyroid hormone secretion and thyroid hormone action, according to Beat Mueller, M.D., et al., in the October 12, 1995 issue of The New England Journal of Medicine.

Before I go blaming Chantix, there is a connection between Hypothyroid and smokers. Smoking is directly related to Hypothyroid so how can anyone say Chantix did this to me when it could have been building over many years and smoking has masked it. We all know smoking and nicotine increase your metabolism so the weight gain doesn’t show up as a symptom. Then we quit smoking and Pow! We get this weight gain that cannot be removed by diet and exercise, and we are fatiqued, almost lethargic when we quit because we all know nicotine is an upper/stimulant. So we are diagnosed with Hypothyroid and we want to blame somebody and Chantix is right there. They do have the warning that rarely it can cause the problem so we know that is a possibility, but not very likely. I would tend to believe that this is another thing that smoking has caused, just like osteoporosis, and I just have to learn to live with it.

How to Tell If You Are Hypothyroid

Here’s how you can determine if you have an underactive thyroid condition called hypothyroidism.

3. Note related conditions, including: recurrent pregnancy loss, resistant high cholesterol, difficult menopause, fibromyalgia, chronic fatigue syndrome, carpal tunnel syndrome, mitral valve prolapse.
4. Meet with your doctor for a thyroid examination and blood test.
5. Request a TSH (thyroid stimulating hormone) blood test, along with T4, T3, Free T4 and Free T3 tests.
6. Review your test results with the doctor.
7. At most labs in the U.S., up until late 2002, the normal range is from around 0.5 to 5.5. That range changed to .3 to 3 as of early 2003. If the TSH level is at the higher end of the range, or above the range, your doctor may determine that you are hypothyroid (underactive thyroid.)
8. If your doctor ran a test called Total T4 or Total Thyroxine, normal range is approximately 4.5 to 12.5. If you had a low reading, and a high TSH, your doctor might consider that indicative of hypothyroidism.
9. If your doctor ran a test called Total T4 or Total Thyroxine, normal range is approximately 4.5 to 12.5. If you had a low reading, and a low TSH, your doctor might look into a possible pituitary problem.
10. If your doctor ran a test called Free T4, or Free Thyroxine, normal range is approximately 0.7 to 2.0. If your result was less than 0.7, your doctor might consider that indicative of hypothyroidism.
11. If your doctor ran a test called Total T3, normal range is approximately 80 to 220. If your result was less than 80, your doctor might consider that indicative of hypothyroidism.
12. If your doctor ran a test called Free T3, the normal range is approximately 2.3 to 4.2. If your result was less than 2.3, your doctor might consider that indicative of hypothyroidism.
13. If your test results come back “normal” but you have many of the symptoms or risk factors for thyroid disease, make sure you ask for an antibodies test. Some doctors believe in treating thyroid symptoms in the presence of elevated antibodies and normal TSH levels.
14. If your test results come back “normal” but you have many of the symptoms or risk factors for thyroid disease, consider going to a reputable holistic M.D. or alternative physician for further interpretation and diagnosis.

Tips:

1. Many people who have radioactive iodine treatment for hyperthyroidism/Graves’ Disease, or who have sugery to remove all or part of the thyroid due to nodules or cancer, are hypothyroid.
2. If you have been treated with radioactive iodine or surgery, and are currently not on thyroid hormone replacement, but have hypothyroidism symptoms, see your doctor.
3. Keep in mind that laboratory normal values vary somewhat from lab to lab. Make sure you find out your lab’s normal ranges and review these with your doctor.

I felt Healthier before I went to the Doctor!

Smoke Free 200 Days!

I went to the Doctor for my “Well Woman” visit. I weigh 173 lbs. Ugggghhhhh!!! I have to have a colonoscopy because I am over 50. Uggghhhhh! I have to have my yearly July 31st. Ugggghhhhh! My osteoporosis rating was T -2.5. last fall and he ask if I was taking my Fosamax and I told him I was going to take care of that myself with Calcium Supplements and Walking. Oh no, he said that won’t do it. I have to rebuild the bone! I have to take osteo medicine. so I am going to call my insurance and see if they will cover the once a year Reclast shot. Uggggghhhh! I hate going to the Doc. I couldn’t eat and was poked & prodded, took blood from my little veins, and had an EKG with hairy legs. Uggggghhhhhh! I’m not doing this again for another 5 -10 years. It’s too much work. Luckily I broke it up by doing the Bone Density and Mammogram last fall and the Chest X-Ray and my Eye-Exam. It’s tough trying to stay healthy.

And did the Doc care that I walk everyday? No, he was not impressed. Did he care that I hadn’t had a cig for 6 months? Kind of happy but didn’t jump up and down or pat me on the back and say, “Good Job”. He didn’t say my lungs sounded better or nothing. He listened to my heart a lot, like even in my neck with the stethoscope. Kind of weird I thought.

Anyway, it all ended with me not being able to pee in the cup so I figured I will do that when I go on the 31st to the Lady Doc there for my yearly. Oh, and the lab gal sent me home with a poop card. Ugggghhhhh! It was a wonderful day…

This Pill has changed my life and not for the better. Mt twin Sister along with my older sister – we all decided to take the chantix drug. After 4 weeks we all became very sick. Leg aches – our feet felt like they were being crushed. So tired could not get out of bed. Terrible dreams – lossing our hair. I thought I was having a heart attack. This medication has ruined my last two years of my life – along with my sisters. We have been doctoring every since. Thyroid problems are the one thing we have figured out and not been able to get under control. There were many days I was in so much pain I just wanted to die. I would never suggest this drug to any one. This needs to be taken off the market. They owe me 2 years of my life back – and who knows how much longer I am going to suffer. Please think good and hard before taking

My reply…

Oh Joan, Thank you so much for sharing your story with me. I am so sorry you had a bad experience with Chantix. I appreciate you sharing your experience.

Everyone who decides to try Chantix needs to be aware of the risks involved. It is such a new drug that you don’t know what all the side effects really are. This Thyroid problem is news to me and I have been trying to follow the effects of Chantix for quite a while now.

Again, thank you for making me aware of this and I wish you and your sisters the best of health and God’s Blessings.

Obviously more research needs to be done. After I Googled “Chantix and Thyroid” I have found some good information that shows Joan’s story is just one of many.

Following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

Post-Marketing Experience:
The following adverse events have been reported during post-approval use of Chantix. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been reports of depressed mood, agitation, changes in behavior, suicidal ideation and suicide in patients attempting to quit smoking while taking Chantix. Smoking cessation with or without treatment is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness. Not all patients had known pre-existing psychiatric illness and not all had discontinued smoking. The role of Chantix in these reports is not known (see WARNINGS).

CHANTIX Safety Information

Important Safety Information

CHANTIX® (varenicline) is indicated as an aid to smoking cessation treatment in adults 18 and over. Patients may benefit from behavioral modification and support during their quit attempt. Patients should be encouraged to continue to attempt to quit if they have early lapses after quit day.

Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. These symptoms as well as worsening of preexisting psychiatric illness have been reported in patients attempting to quit smoking with CHANTIX or after stopping CHANTIX.

The most common adverse reactions include nausea, sleep disturbance, constipation, flatulence, and vomiting. Nausea occurred in 30% of patients; 3% discontinued due to nausea.

Patients should be informed that they may experience vivid, unusual, or strange dreams during treatment with CHANTIX. Patients should be advised to use caution driving or operating machinery until they know how quitting smoking with CHANTIX may affect them.

Safety and efficacy of CHANTIX in combination with other smoking cessation drug therapies have not been studied. Dosage adjustment with CHANTIX is recommended in patients with severe renal impairment or in patients undergoing hemodialysis.

Smoking cessation, with or without treatment with CHANTIX, may alter the pharmacokinetics or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin. Dosage adjustment for these drugs may be necessary.

A winters day
In a deep and dark december;
I am alone,
Gazing from my window to the streets below
On a freshly fallen silent shroud of snow.
I am a rock,
I am an island.
Ive built walls,
A fortress deep and mighty,
That none may penetrate.
I have no need of friendship; friendship causes pain.
Its laughter and its loving I disdain.
I am a rock,
I am an island.

Dont talk of love,
But Ive heard the words before;
Its sleeping in my memory.
I wont disturb the slumber of feelings that have died.
If I never loved I never would have cried.
I am a rock,
I am an island.

I have my books
And my poetry to protect me;
I am shielded in my armor,
Hiding in my room, safe within my womb.
I touch no one and no one touches me.
I am a rock,
I am an island.

Chantix Works. Period. No doubt about it. I have been off of the Chantix for four weeks and off of cigarettes for 154 days. This is all so amazing to me and my family and friends are totally shocked as well.

I have gained 25 pounds and have lost 4 pounds in the last 10 days. My appetite and settled down and I have more energy since I went off the Chantix. In a year after quitting smoking you will go back to your pre-quitting weight. I am not worried about my weight like I was about my lungs. I have been walking every morning and can walk twice as far and not get winded.

I don’t miss the smell or the nicotine film that was on everything I owned. I feel healthier and more energetic every day. No cravings, no coughing, no bronchitis or pneumonia. I don’t have to use my inhaler in the morning or during the day, or ever. The money I have saved has bought me a Digital Camera which I use daily. I have my self-esteem back. Quitting smoking is something I can be proud of and my children are proud of me. Even if I get Cancer tomorrow, at least I quit smoking first.

Please use the Chantix if you can afford it. The first side effects will go away after a few weeks. Hang tough and know that it does work. Don’t try it until you are truly convinced in your mind that you WANT to quit smoking, because Chantix Works and you will quit smoking if you use it so you better WANT to quit because YOU WILL QUIT.

Niccine: a new approach to quit smoking This is a different approach to the quit smoking problem similiar to by the drug maker Pfizer’s Chantix Swedish anti-nicotine vaccine to be tested in Nordic countries “A Swedish vaccine against nicotine will be tested on 400 people in three Nordic countries,” Heavy smokers who would like to quit, will get counselling along with the new drug, initial test will run for 4 months.

Niccine is supposed to help the immune system build antibodies against nicotine.

Interesting approach to the problem: Niccine will latch onto the incoming nicotine and preventing it from reaching the brain’s reward system, thereby preventing the smoker from getting that addictive smoking “kick” or hit. Niccine, has been developed over the course of 10 years by Swedish researchers at the Karolinska Institute, under the guidance of professor Torgny Svensson who founded Independent Pharmaceutica.